Complications related to dialysis procedures

Researchers are collecting detailed data on how well Teleflex's vascular access devices perform and how safe they are when used in everyday medical care. This observational registry aims to gather high-quality evidence on devices like central venous catheters, midline catheters, peripheral catheters, hemodialysis catheters, and arterial catheters, including some with antimicrobial and antithrombogenic features. The study focuses on real-world use following the devices' instructions for use to assess their safety and success. Participants in this registry will have a Teleflex vascular access device placed as part of their therapy or diagnosis. These devices range from central venous catheters to accessories used for their placement and maintenance. The study will observe and record the use of these devices without altering standard care, tracking outcomes such as successful device use and verification of catheter tip positioning. During the study, participants will be monitored for device-related adverse events within seven days after device removal. Data collection will include whether the device was successfully used without needing removal due to complications and confirmation of catheter tip location immediately after removal for certain devices. The registry aims to provide comprehensive real-world safety and performance data over the course of the study, which starts in December 2024 and extends to December 2034.

Researchers are evaluating TS-172 in adults with hyperphosphatemia who are receiving hemodialysis due to chronic kidney disease. This open-label, single-arm clinical study aims to assess how well TS-172 controls serum phosphorus levels in this patient group. The study is sponsored by Taisho Pharmaceutical Co., Ltd. and focuses on patients who have been on hemodialysis three times a week for at least 12 weeks. Participants will receive oral TS-172 once daily at doses ranging from 20 to 60 mg. The study monitors the achievement rate of target serum phosphorus levels by Week 8. Secondary measures include changes in serum phosphorus concentration, corrected serum calcium levels, and the serum calcium-phosphorus product up to Week 8. During the study, participants will undergo regular blood tests to measure phosphorus and calcium levels and monitor parathyroid hormone concentrations. Researchers will track changes from baseline to evaluate treatment effects. The study does not involve blinding or placebo groups. Participants will be followed from screening through Week 8 to assess safety and efficacy outcomes.

This research aims to compare two timings of physical therapy for adults with end-stage renal disease (ESRD) who are undergoing hemodialysis. The study evaluates whether exercising during dialysis sessions or before dialysis leads to better improvements in physical function, quality of life, and laboratory measures such as hemoglobin and electrolyte levels. A total of 72 adult participants will take part in this randomized controlled trial to help determine the best approach to physical therapy in this population. Participants will be randomly assigned to one of two groups. One group will perform supervised physical therapy exercises during their dialysis sessions twice weekly for 12 weeks, while the other group will perform the same exercises before their dialysis sessions on the same schedule. Each session lasts about 30 minutes and includes warm-up, resistance training, and cool-down. Both groups will first receive standardized education about the benefits and safety of exercise before starting the intervention. Throughout the study, participants will undergo assessments including the Six-Minute Walk Test, Five Times Sit-to-Stand Test, and quality of life questionnaires at baseline, every four weeks during the 12-week intervention, and at a 6-month follow-up. Blood tests to measure hemoglobin and electrolyte levels will be done at baseline and at 4, 8, and 12 weeks. The study monitors these outcomes to evaluate the effects of exercise timing on health and well-being for individuals on hemodialysis.

Researchers are evaluating the long-term safety and effectiveness of the drug TS-172 in patients with hyperphosphatemia who are undergoing hemodialysis. This Phase 3 study focuses on patients who have chronic kidney disease and have been receiving hemodialysis or hemodiafiltration three times a week for at least 12 weeks. The study is sponsored by Taisho Pharmaceutical Co., Ltd. and aims to assess the impact of TS-172 on controlling phosphate levels. Participants will receive oral TS-172 at doses ranging from 20 to 60 mg per day while continuing their prescribed phosphate binder regimen without changes in dosage during the study. The trial includes a treatment period lasting up to 52 weeks to monitor the drug's safety and efficacy in managing serum phosphorus levels within a specified range. No placebo or comparator groups are mentioned, and the study is open-label without masking. During the trial, participants will have regular assessments to monitor adverse events and serum phosphorus concentrations. The primary outcome measure is the incidence of adverse events within 26 to 52 weeks of treatment. Patients must meet specific eligibility criteria regarding their dialysis treatment, phosphate binder use, and serum phosphorus levels. The total participation duration will be at least one year from the start of treatment, with safety monitored throughout the study period.

Researchers are conducting a phase 3 trial to study TS-172, an oral drug, in patients with hyperphosphatemia who are on hemodialysis. The study is designed as randomized, placebo-controlled, and double-blind to evaluate the effect of TS-172 combined with phosphate binders. The purpose is to understand how well TS-172 controls serum phosphorus levels in this patient group. Participants will receive either TS-172 at doses of 20 to 60 mg per day or a placebo, both given by mouth. The study involves continuing the use of phosphate binders at stable doses during the trial. The treatment period lasts up to 8 weeks, during which the impact on phosphorus and calcium levels will be assessed. During the trial, participants will have their serum phosphorus, corrected calcium, and calcium-phosphorus product measured regularly, with the main focus on achieving target phosphorus levels by week 8. The study includes careful monitoring of parathyroid hormone levels and follow-up visits to ensure safety and track treatment effects. Overall participation spans the treatment period and related assessments up to 8 weeks.

This research aims to evaluate the effects of thyroid hormone supplementation in patients undergoing hemodialysis who have elevated thyrotropin (TSH) levels, a common complication in chronic kidney disease. Previous studies have shown that higher TSH levels are linked to poorer quality of life and increased cardiovascular risks in these patients. The trial seeks to clarify whether levothyroxine treatment can improve patient-centered outcomes and cardiovascular health, as well as its metabolic effects in this population. Participants will be randomly assigned to receive either levothyroxine or a matching placebo for 24 weeks. Initial doses depend on their TSH levels, with adjustments after 8 and 16 weeks based on follow-up TSH measurements, aiming to maintain TSH within a target range. Both groups undergo similar pill titration schedules to maintain study balance. The trial is double-blind and placebo-controlled to ensure unbiased results. During the study, participants will have assessments of quality of life, coronary artery calcification, physical performance, endothelial function, vascular markers, body fat, muscle strength, heart function, and energy expenditure at baseline and after 24 weeks. These evaluations help researchers determine the impact of levothyroxine on health-related quality of life and cardiovascular parameters. The total study participation spans approximately six months with regular monitoring.

Researchers are evaluating AP301, a novel iron-based phosphate binder, in patients with chronic kidney disease who are receiving maintenance dialysis and have elevated blood phosphate levels. This phase 3, randomized, double-blind study aims to determine whether AP301 lowers blood phosphate and how it affects serum calcium, calcium times phosphate, and intact parathyroid hormone levels. The trial also assesses any discomfort or medical problems during treatment and its impact on quality of life in Chinese patients. Participants will first stop all phosphate-lowering medications. They will then take either AP301 or a low-dose comparator (considered ineffective) three times daily for 8 weeks. Following this, all participants receive AP301 three times daily for 24 weeks, with dose adjustments based on blood phosphate levels and physician judgment. Finally, participants will take either AP301 or the comparator three times daily for 3 weeks. Additional treatments may be given if blood phosphate levels become too high or low. During the study, participants will undergo regular assessments including blood tests to monitor serum phosphate, calcium, and parathyroid hormone levels. Electrocardiogram tests will measure changes in QT intervals. Safety is monitored by tracking adverse events throughout the trial, which lasts up to 37 weeks. The primary outcome is the change in serum phosphate concentration from baseline to the end of week 8, with ongoing evaluations over the entire study period.

Researchers are studying patients with chronic kidney disease who are on hemodialysis and also have heart failure, a condition that worsens their health and prognosis. This study evaluates the use of Vericiguat, a new drug that may improve heart function and exercise ability while lowering the risk of heart-related hospitalization and death. Vericiguat has shown good tolerance in patients with kidney problems, but its effects specifically in dialysis patients need further study. The treatment involves starting patients on a low dose of Vericiguat (2.5 mg taken orally once daily) for two weeks, then increasing to 5 mg once daily if tolerated. If blood pressure rises, doctors may adjust the medication or add blood pressure drugs. The treatment will continue with follow-up for 12 months, with dose adjustments or discontinuation if side effects like low blood pressure occur. Participants will be monitored through various heart and kidney function tests including echocardiograms, blood pressure measurements, blood tests for heart stress markers, and quality of life questionnaires. The main measurement is the change in left ventricular ejection fraction after 12 weeks. Safety and effectiveness will be observed over one year to provide new evidence to improve care for heart failure patients on dialysis.

Researchers are evaluating the safety, tolerability, and effectiveness of AP306 at fixed doses in adults with hyperphosphatemia who are receiving maintenance hemodialysis. Hyperphosphatemia is a common complication in advanced chronic kidney disease and is linked to serious risks such as cardiovascular problems, fractures, and mortality, especially in dialysis patients. This research is a randomized, double-blind, placebo-controlled Phase 2b study to better understand how AP306 affects phosphate levels in this population. Participants will receive AP306 in different fixed doses administered orally either twice or three times daily for 8 weeks, or a placebo given three times daily. The study includes seven different cohorts, six receiving various doses of AP306 and one receiving placebo. The treatment period aims to assess how these doses impact serum phosphate levels and the drug's safety and tolerability. During the study, participants will have their serum phosphate levels monitored to measure the drug's impact over the 8-week treatment period. Researchers will also assess the proportion of participants achieving target phosphate levels and the time it takes to see a response. Safety monitoring will include laboratory tests and assessments of adverse effects. The study expects full participation to span at least 8 weeks of treatment, with ongoing evaluation of tolerability and efficacy.

Researchers are evaluating the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for patients with end-stage renal disease (ESRD) who require hemodialysis and need an arteriovenous graft for vascular access. The study aims to measure the proportion of patients maintaining secondary patency of the graft at 6 months and to monitor adverse events related to the device during this period. Participants will receive the InnAVasc Arteriovenous Graft surgically implanted in the forearm or upper arm using standard vascular surgical techniques. The graft can be placed in a straight configuration in the upper arm or in a looped configuration in the forearm or upper arm, avoiding placement across the elbow. Patients must be able to continue or start antiplatelet therapy after the implant. The study includes periodic follow-up visits and assessments for up to two years after implantation. During the study, participants will undergo assessments to monitor graft function, safety, and successful use for hemodialysis. Researchers will collect data on device patency, adverse events, and the ability to cannulate the graft within seven days of surgery. Follow-up evaluations will continue at multiple time points up to 24 months to assess sustained graft use and patient outcomes. Participants are expected to provide informed consent and attend all scheduled visits throughout the study duration.